US2023127119A1PendingUtilityA1

Systems and methods for producing mixtures

Assignee: Boston Scientific Medical Device LimitedPriority: Oct 22, 2021Filed: Oct 21, 2022Published: Apr 27, 2023
Est. expiryOct 22, 2041(~15.3 yrs left)· nominal 20-yr term from priority
A61M 5/31596A61M 5/19A61J 1/2006A61M 5/2448A61J 1/2048A61M 5/36A61J 1/2068
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Claims

Abstract

A system is disclosed for producing a mixture to deliver to a treatment site. The system can include a connector with a connector vent so that air in the connector is expellable therethrough. A multi-lumen chamber can be connected to a proximal end of the connector and include a first lumen aligned and adjacent a second lumen. The first lumen can be configured to include a first constituent in a proximal portion of the first lumen, a second constituent in a distal portion of the first lumen, and a first plunger internally positioned within the first lumen to distally move the first constituent into the distal portion to mix with the second constituent in a first state to form a first mixture. The second lumen is configured to include a third constituent and a second plunger rod internally positioned within the second to distally move the third constituent.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A system for producing a mixture to deliver to a treatment site, comprising:
 a connector comprising a central lumen attachable to a proximal end of a delivery system, the connector comprising a connector vent in fluid communication with the central lumen configured so that air in the connector is expellable therethrough;   a multi-lumen chamber connected to a proximal end of the connector and comprising a first lumen aligned and adjacent a second lumen;   the first lumen configured to comprise a first constituent in a proximal portion of the first lumen and a second constituent in a distal portion of the first lumen, a first plunger internally positioned within the first lumen to distally move the first constituent into the distal portion to mix with the second constituent in a first state to form a first mixture, the first lumen terminating in a first port;   the second lumen configured to comprise a third constituent, a second plunger rod internally positioned within the second to distally move the third constituent, the second lumen terminating in a second port;   wherein distally moving the second plunger rod causes the third constituent to be delivered through the first and second ports, vent air from system through the connector vent, mix within the central lumen of the connector to form the mixture, and delivered through the delivery system.   
     
     
         2 . The system of  claim 1 , wherein the second plunger rod distally moves the third constituent and the first mixture in the second state. 
     
     
         3 . The system of  claim 1 , wherein distally moving the second plunger rod causes the first mixture and the third constituent to be delivered through the first and second ports while venting air from the system through the connector vent. 
     
     
         4 . The system of  claim 1 , wherein at least one of the first and second lumens comprise a floating plunger, wherein at least one of the first and second floating plungers are toggleable when a predetermined pressure is achieved within a respective lumen. 
     
     
         5 . The system of  claim 1 , the delivery system comprising a needle assembly removably connected to the connector, the needle assembly comprising the needle and a needle hub positioned at a proximal end of the needle. 
     
     
         6 . The system of  claim 5 , wherein at least one of the first and second lumens comprise a floating plunger,
 wherein the first lumen comprises an internally positioned rib at or adjacent a distal end of the first lumen,   wherein as the first plunger rod is advanced distally, the first floating plunger advances distally and contacts the rib to develop a moment on a head of the first floating plunger causing the first floating plunger to tilt and break a fluid seal so fluid within the first lumen can advance distal of the first floating plunger.   
     
     
         7 . The system of  claim 1 , wherein the central lumen of the connector comprises a static mixer and wherein the connector vent extends orthogonally from the central lumen to outside air distal of the static mixer. 
     
     
         8 . The system of  claim 1 , wherein the connector vent further comprises a one-way valve configured to permit egress of air from the central lumen. 
     
     
         9 . The system of  claim 1 , wherein the first lumen comprises a vent proximal of the first port and orthogonal to the first lumen configured to permit egress of air from the first lumen. 
     
     
         10 . The system of  claim 1 , wherein the first mixture and the third fluid mixed together forms a hydrogel, and wherein the connector vent is configured to prevent air bubbles from entering the hydrogel. 
     
     
         11 . The system of  claim 1 , wherein the connector vent comprises an air-permeable-fluid-impermeable membrane. 
     
     
         12 . The system of  claim 1 , wherein the first lumen, the first plunger assembly, and the second plunger rod are each comprised in a plunger assembly; and
 wherein the plunger assembly is nestable within the second lumen.   
     
     
         13 . The system of  claim 1 , wherein the second constituent is polyethylene glycol. 
     
     
         14 . A method for producing a mixture with a mixing system to deliver to a treatment site, the mixing system comprising:
 a multi-lumen chamber comprising a first lumen aligned and adjacent a second lumen;   the first lumen configured to comprise a first constituent in a proximal portion of the first lumen and a second constituent in a distal portion of the first lumen, a first plunger internally positioned within the first lumen to distally move the first constituent into the distal portion to mix with the second constituent in a first state to form a first mixture, the first lumen terminating in a first port;   the second lumen configured to comprise a third constituent, a second plunger rod internally positioned within the second to distally move the third constituent, the second lumen terminating in a second port, the method comprising:   distally moving the first constituent, by the first plunger rod, to open a barrier within the first lumen thereby injecting the first constituent into the distal portion to mix with the second constituent in a first state to form a first mixture;   purging air from the distal portion and a second lumen of the multi-lumen chamber through a connector port of a connector positioned on a distal end of the multi-lumen chamber, the connector comprising a central lumen attached to a distal end of a needle hub; and   distally moving the second plunger rod causing the first mixture and the third constituent to be delivered through the first and second ports, mixed together within the central lumen of the connector to form the mixture.   
     
     
         15 . The method of  claim 14 , wherein the second plunger rod distally moves the third constituent and the first mixture in the second state. 
     
     
         16 . The method of  claim 14 , wherein the step of distally moving the second plunger rod to form the mixture is performed while the step of purging air through the connector port. 
     
     
         17 . The method of  claim 14 , further comprising:
 injecting the mixture, from the connector and the needle, between a first layer of a prostate and a second layer of tissue of a rectum, wherein the mixture at least partially separates the first and second layers.   
     
     
         18 . The method of  claim 14 , wherein at least one of the first and second lumens comprise a floating plunger, the method further comprising:
 positioning a rib within at least the first lumen a distal end of the first lumen; and   advancing distally the first plunger rod so that the first floating plunger advances distally and contacts the rib thereby developing a moment on a head of the first floating plunger causing the first floating plunger to tilt and break a fluid seal so fluid within the first lumen advances distal of the first floating plunger.   
     
     
         19 . The method of  claim 14 , further comprising:
 preventing, by the connector port, air bubbles from entering the mixture.

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